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1. 发明申请

WO2008025528A1 METHOD FOR THE PRODUCTION OF CONJUGATES OF INSULIN-LIKE GROWTH FACTOR-I AND POLY(ETHYLENE GLYCOL) 审中-公开
标题翻译：生产胰岛素样生长因子-1和聚（乙二醇）的方法
公开(公告)号：WO2008025528A1
公开(公告)日：2008-03-06
申请号：PCT/EP2007/007540
申请日：2007-08-29
申请人： F. HOFFMANN-LA ROCHE AG , FISCHER, Stephan , HESSE, Friederike , KNOETGEN, Hendrik , LANG, Kurt , METZGER, Friedrich , REGULA, Joerg, Thomas , SCHANTZ, Christian , SCHAUBMAR, Andreas , SCHOENFELD, Hans, Joachim
发明人： FISCHER, Stephan , HESSE, Friederike , KNOETGEN, Hendrik , LANG, Kurt , METZGER, Friedrich , REGULA, Joerg, Thomas , SCHANTZ, Christian , SCHAUBMAR, Andreas , SCHOENFELD, Hans, Joachim
IPC分类号： A61K47/48 , C07K14/65 , C12N15/62 , C12N15/12 , C12N9/52
CPC分类号： C07K14/65 , A61K47/60 , C07K2319/21 , C07K2319/50
摘要： Method for the production of a lysine-PEGylated IGF-I or IGF-I variant, said variant comprising one or two amino acid(s) selected from the group consisting of lysine 27, 65 and/or 68 substituted independently by another polar amino acid, characterized in cultivating a prokaryotic host cell comprising an expression vector containing a nucleic acid encoding a fusion protein comprising said IGF-I or IGF-I variant N-terminally linked to the C-terminus of a propeptide, that said propeptide ends C-terminally with amino acids -Y-Pro, wherein Y is selected from the group consisting of Pro, Pro-Ala, Pro-Gly, Pro-Thr, Ala-Pro, Gly-Pro, Thr-Pro, Arg-Pro, or Pro-Arg-Pro, recovering and PEGylating said fusion protein, cleaving said PEGylated fusion protein with IgA protease, and recovering said PEGylated IGF-I or IGF-I variant. The PEGylated IGF-I or IGF-I variant is useful for the treatment of neurodegenerative disorders like Alzheimer's Disease.
摘要翻译：用于生产赖氨酸 - PEG化IGF-I或IGF-I变体的方法，所述变体包含一个或两个选自由另一极性氨基酸独立取代的赖氨酸27,65和/或68的氨基酸其特征在于培养原核宿主细胞，所述原核宿主细胞包含含有编码融合蛋白的核酸的表达载体，所述核酸编码融合蛋白，所述融合蛋白包含与前肽的C-末端N末端连接的所述IGF-I或IGF-I变体，所述前肽终止于C-末端与氨基酸-Y-Pro，其中Y选自Pro，Pro-Ala，Pro-Gly，Pro-Thr，Ala-Pro，Gly-Pro，Thr-Pro，Arg-Pro或Pro- Arg-Pro，回收和PEG化所述融合蛋白，用IgA蛋白酶切割所述聚乙二醇化融合蛋白，并回收所述聚乙二醇化IGF-I或IGF-I变体。聚乙二醇化IGF-I或IGF-I变体可用于治疗神经变性疾病如阿尔茨海默病。

2. 发明申请

WO2006066891A2 CONJUGATES OF INSULIN-LIKE GROWTH FACTOR-1 AND POLY(ETHYLENE GLYCOL) 审中-公开
标题翻译：胰岛素样生长因子-1和聚（乙二醇）的结合
公开(公告)号：WO2006066891A2
公开(公告)日：2006-06-29
申请号：PCT/EP2005013756
申请日：2005-12-21
申请人： HOFFMANN LA ROCHE , AMREIN BEAT , FOSER STEFAN , LANG KURT , METZGER FRIEDRICH , REGULA JOERG , SCHAUBMAR ANDREAS , HESSE FRIEDERIKE , KUENKELE KLAUS-PETER , LANZENDOERFER MARTIN
发明人： AMREIN BEAT , FOSER STEFAN , LANG KURT , METZGER FRIEDRICH , REGULA JOERG , SCHAUBMAR ANDREAS , HESSE FRIEDERIKE , KUENKELE KLAUS-PETER , LANZENDOERFER MARTIN
IPC分类号： A61K47/48
CPC分类号： A61K47/60 , A61K47/48215 , C07K14/475 , C07K14/65
摘要： A conjugate consisting of an insulin-like growth factor-1 (IGF-I) variant and one or two poly(ethylene glycol) group(s), characterized in that said IGF-I variant has an amino acid alteration at up to three amino acid positions 27, 37, 65, 68 of the wild-type IGF-I amino acid sequence so that one or two of said amino acids is/are lysine and amino acid 27 is a polar aminio acid but not lysine, is conjugated via the primary amino group(s) of said lysine(s) and said poly(ethylene glycol) group(s) have an overall molecular weight of from 20 to 100 kDa is disclosed. This conjugate is useful for the treatment of neurodegenerative disorders like Alzheimer's Disease.
摘要翻译：由胰岛素样生长因子-1（IGF-I）变体和一个或两个聚（乙二醇）基团组成的缀合物，其特征在于所述IGF-1变体在至多三个氨基酸处具有氨基酸改变野生型IGF-I氨基酸序列的酸性位置27,37,65,68，使得一个或两个所述氨基酸是赖氨酸，氨基酸27是极性氨基酸而不是赖氨酸，通过公开了所述赖氨酸和所述聚（乙二醇）基团的伯氨基的总分子量为20至100kDa。该缀合物可用于治疗神经变性疾病如阿尔茨海默病。

3. 发明申请

WO2009121759A3 USE OF PEGYLATED IGF-I VARIANTS FOR THE TREATMENT OF NEUROMUSCULAR DISORDERS 审中-公开
公开(公告)号：WO2009121759A3
公开(公告)日：2009-10-08
申请号：PCT/EP2009/053465
申请日：2009-03-24
申请人： F. HOFFMANN-LA ROCHE AG , HOLTMANN, Bettina , METZGER, Friedrich , SENDTNER, Michael
发明人： HOLTMANN, Bettina , METZGER, Friedrich , SENDTNER, Michael
IPC分类号： A61K47/48 , A61P25/00
摘要： The present invention relates to the pharmaceutical use of polyethylene glycol-(PEG)ylated IGF-I variants for the treatment, prevention and/or delay of progression of neuromuscular disorders, in particular amyotrophic lateral sclerosis (ALS). More specifically, the present invention relates to the use of a PEGylated IGF-I variant for the manufacture of a pharmaceutical composition for the treatment, prevention and/or delay of neuromuscular disorders, in particular ALS wherein the PEGylated IGF-I variant is characterized in that it is derived from the wild- type human IGF-I amino acid sequence (SEQ ID NO: 1) and carries one or two amino acid alterations at amino acid positions 27, 65 and 68 so that one or two of amino acids at positions 27, 65 and 68 is/are a polar amino acid but not lysine and PEG is attached to at least one lysine residue.

4. 发明申请

WO2006066891A3 CONJUGATES OF INSULIN-LIKE GROWTH FACTOR-1 (IGF-1) AND POLY(ETHYLENE GLYCOL) 审中-公开
公开(公告)号：WO2006066891A3
公开(公告)日：2006-06-29
申请号：PCT/EP2005/013756
申请日：2005-12-21
申请人： F. HOFFMANN-LA ROCHE AG , AMREIN, Beat , FOSER, Stefan , LANG, Kurt , METZGER, Friedrich , REGULA, Jörg , SCHAUBMAR, Andreas , HESSE, Friederike , KUENKELE, Klaus-Peter , LANZENDOERFER,Martin
发明人： AMREIN, Beat , FOSER, Stefan , LANG, Kurt , METZGER, Friedrich , REGULA, Jörg , SCHAUBMAR, Andreas , HESSE, Friederike , KUENKELE, Klaus-Peter , LANZENDOERFER,Martin
IPC分类号： A61K47/48
摘要： A conjugate consisting of an insulin-like growth factor-1 (IGF-I) variant and one or two poly(ethylene glycol) group(s), characterized in that said IGF-I variant has an amino acid alteration at up to three amino acid positions 27, 37, 65, 68 of the wild-type IGF-I amino acid sequence so that one or two of said amino acids is/are lysine and amino acid 27 is a polar aminio acid but not lysine, is conjugated via the primary amino group(s) of said lysine(s) and said poly(ethylene glycol) group(s) have an overall molecular weight of from 20 to 100 kDa is disclosed. This conjugate is useful for the treatment of neurodegenerative disorders like Alzheimer's Disease.

5. 发明申请

WO2009121759A2 USE OF PEGYLATED IGF-I VARIANTS FOR THE TREATMENT OF NEUROMUSCULAR DISORDERS 审中-公开
标题翻译：用于治疗神经性疾病的聚乙二醇化IGF-I变体的应用
公开(公告)号：WO2009121759A2
公开(公告)日：2009-10-08
申请号：PCT/EP2009053465
申请日：2009-03-24
申请人： HOFFMANN LA ROCHE , HOLTMANN BETTINA , METZGER FRIEDRICH , SENDTNER MICHAEL
发明人： HOLTMANN BETTINA , METZGER FRIEDRICH , SENDTNER MICHAEL
IPC分类号： A61K47/48 , A61P25/00
CPC分类号： A61K38/30 , A61K47/60 , C07K14/475
摘要： The present invention relates to the pharmaceutical use of polyethylene glycol-(PEG)ylated IGF-I variants for the treatment, prevention and/or delay of progression of neuromuscular disorders, in particular amyotrophic lateral sclerosis (ALS). More specifically, the present invention relates to the use of a PEGylated IGF-I variant for the manufacture of a pharmaceutical composition for the treatment, prevention and/or delay of neuromuscular disorders, in particular ALS wherein the PEGylated IGF-I variant is characterized in that it is derived from the wild- type human IGF-I amino acid sequence (SEQ ID NO: 1) and carries one or two amino acid alterations at amino acid positions 27, 65 and 68 so that one or two of amino acids at positions 27, 65 and 68 is/are a polar amino acid but not lysine and PEG is attached to at least one lysine residue.
摘要翻译：本发明涉及用于治疗，预防和/或延缓神经肌肉疾病，特别是肌萎缩性侧索硬化（ALS）进展的聚乙二醇 - （PEG）的IGF-I变体的药物用途。更具体地说，本发明涉及PEG化IGF-1变体在制备用于治疗，预防和/或延迟神经肌肉疾病，特别是ALS的药物组合物中的用途，其中PEG化的IGF-1变体的特征在于其衍生自野生型人IGF-I氨基酸序列（SEQ ID NO：1），并在氨基酸位置27,65和68处携带一个或两个氨基酸改变，使得位置处的一个或两个氨基酸 27,65和68是极性氨基酸而不是赖氨酸，PEG连接至至少一个赖氨酸残基。

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